A dynamic international contract research organisation seeks a highly motivated candidate to join its team.
Study Start-up Manager
Immediate start
As Study Start-up Manager, you will drive the initiation phase of clinical studies in the field of minimally invasive, image-guided therapies. You will be responsible for the efficient and compliant set-up of clinical research projects, from protocol finalisation through site activation and regulatory approvals, and ensure a seamless transition into the study execution phase.
You will act as a central interface between cross-functional teams, investigators, and external stakeholders during start-up, and contribute to the development of robust, scalable processes within Next Research.
You will work closely with principal investigators, study steering committees, and internal teams, ensuring that all start-up activities are conducted in compliance with Good Clinical Practice and international standards such as ISO 14155.
Study Start-up Management
Lead all aspects of study start-up, including protocol (CIP) finalisation, feasibility assessments, site selection, and site activation
Develop and maintain start-up timelines and ensure timely study initiation
Coordinate and execute regulatory and ethics submissions in collaboration with relevant stakeholders
Cross-functional Collaboration
Work closely with Data Management, Project Management, and other internal teams to ensure efficient study initiation
Ensure structured and effective handover to the Project Management team once enrolment begins
Facilitate communication of study start-up progress to internal and external stakeholders
Study Design & Documentation
Contribute to study design in collaboration with cross-functional teams and Steering Committees
Develop and maintain key study documents (e.g. CIP, CRFs, ICFs)
Ensure all documentation is consistent, feasible, and aligned with study objectives
Ensure compliance with GCP, ISO 14155, and applicable regulatory requirements
Stakeholder Engagement
Liaise with investigators, study sites, regulatory authorities, and ethics committees
Support and guide sites and stakeholders through start-up processes
Provide regular updates to internal stakeholders and senior management
University degree in a relevant healthcare or scientific field
~3-5 years of clinical research project management experience
Familiarity with GCP, ISO 14155 and regulatory/ethics submission processes
Strong organisational and coordination skills with attention to detail
Ability to manage multiple parallel start-up activities and stakeholders
Excellent written and verbal communication skills in English
Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Next Research is based in Vienna's 1st district and offers a friendly and open working atmosphere in an exciting and dynamic field of medicine as well as a fair payment scheme and travel opportunities (approx. 2-3 times annually). The minimum starting salary is € 3200 - negotiable depending on additional qualifications and relevant work experience.
JBRP2_AT